BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS

    MDR report key: 272202 · Received March 31, 2000

    Report

    Report Number
    272202
    Event Type
    Other
    Date Received
    March 31, 2000
    Date of Event
    February 28, 2000
    Report Date
    March 7, 2000
    Manufacturer
    FRESENIUS USA
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FIVE MINUTES INTO TREATMENT, VENOUS LINE DETACHED FROM TESIO CATH. VENOUS LINE AND ARTERIAL LINES WERE CLAMPED AS THE VENOUS ALARM WAS ALARMING. ESTIMATED BLOOD LOSS 200CC. THE PT WAS PLACED IN TRENDELENBURG POSITION ON LEFT SIDE. MD NOTIFIED; LABS OBTAINED. PT COMPLETED TREATMENT AND WAS DISCHARGED TO HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS VENOUS LINE FOR HEMODIALYSIS FKJ FRESENIUS USA 03-7303-5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other 2. VENOUS BLOOD LINE.| 1. FRESENIUS 20008H MACHINE,